Instrument Access Device

ABSTRACT

An instrument access device comprises first, second and third instrument seals for sealing around instruments extended through the device. The seals have respective connector sleeves. Each sleeve connects a base to one of the instrument seals. The device also comprises two insufflation/desufflation ports. Each of the ports comprises a connector extending from the base, a tube extending from the connector, a luer connector and a removable cap. The luer connector is used for connection to any suitable supply line for insufflation gas or for discharge if insufflation gas. In use, the insufflation/desufflation ports facilitate independent control of insufflation and desufflation as may be required during a surgical procedure. Access sleeve at the proximal end is cut-off, folded over the inner proximal ring and is held in place between the base and the inner proximal ring when the base is fitted. The proximal end of the sleeve that is generated when the sleeve is pulled upwardly to retract an incision is removed from the field of use.

This application is a Continuation-In-Part of U.S. application Ser. No.12/133,827, filed Jun. 5, 2008 which claims the benefit of U.S.Provisional Application Nos. 60/924,918, filed Jun. 5, 2007; 60/935,625,filed Aug. 22, 2007; and 60/996,760 filed Dec. 4, 2007.

This application also claims the benefit of U.S. Provisional ApplicationNos. 61/147,625 filed on Jan. 27, 2009, and 61/147,613 filed on Jan. 27,2009.

The entire contents of all of these applications are incorporated hereinby reference.

INTRODUCTION

This invention relates to an instrument insertion device and aninstrument access system incorporating the instrument insertion device.The invention also relates to an instrument access device.

STATEMENTS OF INVENTION

The device of the invention comprises at least one instrument seal toeffect a seal around at least one instrument extended through thedevice, the instrument seal being configured to be arranged in sealingrelationship to a body of a patient. The device preferably has a distalanchoring member for location within a wound interior. The devicepreferably also has a retractor member extending proximally from thedistal anchoring member to retract laterally the sides of a woundopening. Preferably the device comprises a first instrument seal toeffect a seal around a first instrument extended through the device, anda second instrument seal to effect a seal around a second instrumentextended through the device. By providing the two seal arrangement, thisensures that insertion or manipulation or removal of the secondinstrument does not adversely effect the seal around the firstinstrument. The device may comprise a third instrument seal to effect aseal around a third instrument extended through the device. The firstinstrument seal may be spaced apart from the second instrument seal. Thefirst instrument seal may be formed separately from the secondinstrument seal. The first instrument seal may have a larger radialdimension than the second instrument seal. The instrument seal may be ofa gelatinous elastomeric material.

In one case the device comprises a proximal member for locationexternally of a wound opening. The retractor member may extend at leastbetween the distal anchoring member and the proximal member. Theretractor member may extend in two layers between the distal anchoringmember and the proximal member. A first end portion of the retractormember may be fixed to the proximal member. The retractor member may bemovable relative to the distal anchoring member. A second end portion ofthe retractor member may be movable relative to the proximal member. Theretractor member may extend distally from the proximal member to thedistal anchoring member, may be looped around the distal anchoringmember, and may extend proximally from the distal anchoring member tothe proximal member. The proximal member may comprise an inner part andan outer part. The retractor member may extend between the inner partand the outer part.

In another embodiment the instrument seal is spaced proximally of theproximal member. The device may comprise at least one connector memberto connect the proximal member to the at least one instrument seal. Theconnector member facilitates a degree of lateral movement of theinstrument while maintaining the seal. The connector member may comprisea sleeve. The connector member may be of a laterally flexible material.The connector member may be of a longitudinally rigid material. Theconnector member may be of a rubber-like material. The connector membermay be of a longitudinally flexible material.

In another case the instrument seal is mounted to the connector member.The instrument seal may be releasably mounted to the connector member.The instrument seal may comprise a mounting part to mount the instrumentseal to the connector member. The mounting part may be of a rigidmaterial. The instrument seal may comprise a sealing part to effect aseal around an instrument extended through the device, the sealing partbeing overmoulded over at least part of the mounting part.

In one embodiment the connector member is mounted to the proximalmember. The connector member may be releasably mounted to the proximalmember. The connector member may be mounted to the proximal member in aninterference fit arrangement. The connector member may be mounted to theproximal member in a snap-fit arrangement. The connector member maycomprise at least one protrusion for engagement with the proximalmember. The protrusion can be resilient. The device may comprise a clampmember to clamp the connector member to the proximal member. Theconnector member may be inclined relative to the proximal member. Thedevice may comprise a reinforcement element to reinforce the connectormember. The reinforcement element may be of a rigid material. Thereinforcement element may be embedded within the connector member.

The invention also provides a method of performing a surgical procedureutilising the device of the invention.

According to the invention there is provided a method of performing asurgical procedure comprising the steps of:

providing an instrument access device comprising at least one instrumentseal, a distal anchoring member, and a retractor member extendingproximally from the distal anchoring member;inserting the distal anchoring member within the wound interior;retracting laterally the sides of the wound opening using the retractingmember;inserting one or more surgical instruments through the instrument sealinto the wound opening;severing one or more body parts in the wound interior; andremoving the one or more body parts through the wound opening.

In one embodiment of the invention the method comprises the step ofcreating the wound opening. The wound opening may be created by creatinga skin incision, and subsequently forcing tissue apart. The woundopening may be created using a Hasson cut-down incision.

In one case the method comprises the step of inserting an instrumentaccess device at least partially through the wound opening. Theinstrument access device may be inserted at least partially through thewound opening using an introducer device. The method may comprise thestep of inserting at least part of the instrument access device into theintroducer device. The method may comprise the step of inserting theintroducer device at least partially through the wound opening. Themethod may comprise the step of ejecting at least part of the instrumentaccess device from the introducer device within the wound interior. Themethod may comprise the step of removing the introducer device from thewound opening.

In another embodiment the method comprises the step of retracting thewound opening.

In another case the method comprises the step of insufflating the woundinterior.

In one embodiment the one or more surgical instruments are insertedthrough the instrument access device. The one or more body parts may beremoved through the instrument access device. The one or more body partsmay be removed through one or more seal members of the instrument accessdevice. The method may comprise the step of detaching one or more sealmembers of the instrument access device from a retractor member of theinstrument access device. The one or more body parts may be removedthrough the retractor member.

The surgical instrument may comprise a shaft having at least one bend inthe shaft. The bend may be a fixed bend. The surgical instrument maycomprise a shaft and an end effector at a distal end of the shaft. Theend effector may be rotatable relative to the shaft.

In one case the method comprises a method of performing a laparoscopicsurgical procedure. In another case the method comprises a method ofperforming a cholecystectomy procedure.

According to the invention there is provided an instrument access devicecomprising a first instrument seal to effect a seal around a firstinstrument extended through the device, and a second instrument seal toeffect a seal around a second instrument extended through the device,the instrument seals being configured to be arranged in sealingrelationship to a body of a patient; a distal anchoring member forlocation within a wound interior; a retractor member extendingproximally from the distal anchoring member to retract laterally thesides of a wound opening; a proximal member for location externally of awound opening; and a connector member to connect the proximal member tothe instrument seal, the proximal member and the connector member beingconfigured for retaining a proximal end of the retractor member.

In one embodiment the connector member is engagable with the proximalmember.

In one case the outer radial dimension of the connector member isgreater than that of the proximal member. In another case the outerradial dimension of the connector member is less than that of theproximal member. In this case the connector member may comprise an innercollar for engagement with the proximal member.

The connector member may comprise an outer collar for engagement withthe proximal member.

In one embodiment the connector member is releasably mounted to theproximal member.

The connector member may be mounted to the proximal member in aninterference fit arrangement.

The connector member may be mounted to the proximal member in a snap-fitarrangement. The connector member may comprise at least one protrusionfor engagement with the proximal member.

In one embodiment the device comprises a third instrument seal to effecta seal around a third instrument extended through the device.

The first instrument seal may be spaced apart from the second instrumentseal.

The first instrument seal may be formed separately from the secondinstrument seal.

In one embodiment the first instrument seal has a larger radialdimension than the second instrument seal.

In one embodiment the retractor member extends at least between thedistal anchoring member and the proximal member. The retractor membermay extend in two layers between the distal anchoring member and theproximal member.

In one case a first end portion of the retractor member is fixed to theproximal member.

The retractor member may be movable relative to the distal anchoringmember.

In one case a second end portion of the retractor member is movablerelative to the proximal member.

In one embodiment the retractor member extends distally from theproximal member to the distal anchoring member, is looped around thedistal anchoring member, and extends proximally from the distalanchoring member to the proximal member.

In one case the proximal member comprises an inner part and an outerpart. The retractor member may extend between the inner part and theouter part.

In one embodiment at least one of the instrument seal is spacedproximally of the proximal member.

The connector member may comprise a sleeve.

In one embodiment the connector member is of a laterally flexiblematerial.

The connector member may be of a longitudinally rigid material.

The connector member may be of a rubber-like material.

In another case the connector member is of a longitudinally flexiblematerial.

In one case the instrument seal is mounted to the connector member. Theinstrument seal may be releasably mounted to the connector member. Theinstrument seal may comprise a mounting part to mount the instrumentseal to the connector member. The mounting part may be of a rigidmaterial.

In one case the connector member is inclined relative to the proximalmember.

The device may comprise a reinforcement element to reinforce theconnector member. The reinforcement element may be of a rigid material.The reinforcement element may be embedded within the connector member.

In another aspect the invention provides an instrument access devicecomprising a first instrument seal to effect a seal around a firstinstrument extended through the device, and a second instrument seal toeffect a seal around a second instrument extended through the device,the instrument seals being configured to be arranged in sealingrelationship to a body of a patient; the device comprising at least twoports for insufflation and/or desufflation.

The device may comprise an insufflation port and a desufflation port.The ports may be laterally spaced-apart.

In one embodiment the port comprises a connector member. The connectormember may comprise a sleeve. The connector member may be of a laterallyflexible material. The connector member may be of a longitudinally rigidmaterial. The connector member may be of a rubber-like material.

According to the invention there is provided an instrument insertiondevice comprising: —

-   -   a lipseal through which an instrument is insertable; and    -   a second seal member having a passageway extending therethrough,        through which an instrument is insertable.

In one embodiment the second passageway is movable between an openconfiguration, and a sealed configuration to seal around an instrumentinserted through the second passageway. The second passageway may bemovable from the open configuration to the sealed configuration uponinsertion of an instrument through the second passageway.

In one embodiment the second seal member comprises a duckbill valve.

The lipseal may be located proximally of the second seal member.

Preferably the lipseal is longitudinally spaced apart from the secondseal member.

In one case the lipseal is provided in a lipseal housing and the secondseal member is provided in a second seal housing.

In one embodiment the lipseal housing is movable relative to the secondseal housing. The lip seal housing may comprise a cap for the secondseal housing. The lipseal housing may be removable from the second sealhousing. In one case the lipseal housing is releasably connected to thesecond seal housing. The lipseal housing may be connected to the secondseal housing by a hinge connection. The hinge connection may comprise astrap.

In one embodiment the lipseal housing comprises a reducer cap.

In another aspect the invention also provides an instrument accessdevice comprising a first instrument insertion device of the inventionto effect a seal around a first instrument extended through the device,and preferably also a second instrument insertion device of theinvention to effect a seal around a second instrument extended throughthe device, the instrument insertion devices being configured to bearranged in sealing relationship to a body of a patient; a distalanchoring member for location within a wound interior; and a retractormember extending proximally from the distal anchoring member to retractlaterally the sides of a wound opening.

In one embodiment the device comprises a third instrument insertiondevice as claimed in any of claims 1 to 14 to effect a seal around athird instrument extended through the device.

The first instrument insertion device is preferably spaced apart fromthe second instrument insertion device.

In one case the first instrument insertion device is formed separatelyfrom the second instrument insertion device. The first instrumentinsertion device may have a larger radial dimension than the secondinstrument insertion device.

In one embodiment the device comprises a proximal member for locationexternally of a wound opening. The retractor member preferably extendsat least between the distal anchoring member and the proximal member.The retractor member may extend in two layers between the distalanchoring member and the proximal member. A first end portion of theretractor member may be fixed to the proximal member.

In one case the retractor member is movable relative to the distalanchoring member.

A second end portion of the retractor member may be movable relative tothe proximal member.

In one embodiment the retractor member extends distally from theproximal member to the distal anchoring member, is looped around thedistal anchoring member, and extends proximally from the distalanchoring member to the proximal member.

The proximal member may comprise an inner part and an outer part. Theretractor member preferably extends between the inner part and the outerpart.

In one embodiment at least one of the instrument insertion devices isspaced proximally of the proximal member. In this case the device maycomprise at least one connector member to connect the proximal member tothe instrument insertion device. The connector member may comprise asleeve. The connector member may be of a laterally flexible material.The connector member may be of a longitudinally rigid material. Theconnector member is of a rubber-like material.

In another case the connector member is of a longitudinally flexiblematerial. In one embodiment the instrument insertion device is mountedto the connector member. The instrument insertion device may bereleasably mounted to the connector member.

In one case the instrument insertion device comprises a mounting part tomount the instrument insertion device to the connector member. Themounting part may be of a rigid material.

In one embodiment the connector member is mounted to the proximalmember. The connector member may be releasably mounted to the proximalmember. The connector member may be mounted to the proximal member in aninterference fit arrangement. The connector member may be mounted to theproximal member in a snap-fit arrangement. The connector member maycomprise at least one protrusion for engagement with the proximalmember.

In one embodiment the device comprises a clamp member to clamp theconnector member to the proximal member.

In one case the connector member is inclined relative to the proximalmember.

The device may comprise a reinforcement element to reinforce theconnector member. The reinforcement element may be of a rigid material.The reinforcement element may be embedded within the connector member.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example only,with reference to the accompanying drawings, in which: —

FIG. 1 is an isometric view of an instrument access device according tothe invention;

FIG. 2 is a side view of the instrument access device of FIG. 1;

FIG. 3 is a cross-sectional, side view of the instrument access deviceof FIG. 1;

FIGS. 4 and 5 are views similar to FIGS. 1 and 2 of another instrumentaccess device according to the invention;

FIGS. 6 and 7 are views similar to FIGS. 1 and 3 of another instrumentaccess device according to the invention;

FIG. 8 is an isometric view of an instrument seal of the instrumentaccess device of FIGS. 6 and 7;

FIG. 9 is a cross-sectional, side view of the instrument seal of FIG. 8;

FIG. 10 is an isometric view of a mounting part of the instrument accessdevice of FIGS. 6 and 7;

FIG. 11 is an isometric view of another instrument access deviceaccording to the invention;

FIG. 12 is a cross-sectional, side view of the instrument access deviceof FIG. 11;

FIGS. 13 and 14 are respectively isometric and cross sectional views ofanother instrument access device of the invention;

FIGS. 15 and 16 are isometric views of another instrument access deviceaccording to the invention, in use;

FIG. 17 is an exploded, isometric view of another instrument accessdevice according to the invention;

FIG. 18 is a view similar to FIG. 3 of the instrument access device ofFIG. 17;

FIGS. 19 to 21 are views similar to FIG. 3 of another instrument accessdevice according to the invention, in use;

FIG. 22 is a view similar to FIG. 3 of another instrument access deviceaccording to the invention;

FIG. 23 is a plan view of the instrument access device of FIG. 22;

FIG. 24 is a plan view of part of the instrument access device of FIG.22;

FIG. 25 is a view similar to FIG. 3 of the instrument access device ofFIG. 22, in use;

FIG. 26 is an isometric view of a pack;

FIG. 27 is an isometric view of medical devices suitable for use inperforming a surgical procedure according to the invention;

FIGS. 28 to 36 are isometric views illustrating insertion of aninstrument access device into a wound opening;

FIGS. 37 to 44 are isometric views illustrating performing a surgicalprocedure using surgical instruments inserted through the instrumentaccess device of FIGS. 28 to 36;

FIGS. 45 to 48 are isometric views illustrating removal of a body partthrough the instrument access device of FIGS. 28 to 36;

FIG. 49 is an exploded isometric view of an instrument access device ofthe invention;

FIG. 50 is an isometric, partially exploded view of another instrumentaccess device according to the invention;

FIG. 51 is an isometric view of a further instrument access device ofthe invention;

FIG. 52 is an isometric, partially exploded view of another instrumentaccess device of the invention;

FIG. 53 is an isometric view of an instrument access device according tothe invention;

FIG. 54 is an exploded isometric view of an instrument insertion deviceof the invention;

FIG. 55 is an isometric view of the assembled device of FIG. 54;

FIG. 56 is a view similar to FIG. 55 with a cap opened;

FIG. 57 is cross sectional view of the instrument seal device of FIGS.54 to 56;

FIG. 58 is a cross sectional view of an alternative instrument sealdevice;

FIG. 59 is a cross sectional view of another instrument seal device;

FIGS. 60 to 62 are cross sectional views of various sealing devices; and

FIGS. 63( a) to 63(c) are views of the device of FIG. 53, in use.

DETAILED DESCRIPTION

Referring to the drawings, and initially to FIGS. 1 to 3 thereof, thereis illustrated an instrument access device 1 according to the invention.The device 1 is suitable for use during laparoscopic surgery tofacilitate instrument access to an insufflated abdominal cavity whilemaintaining pneumoperitoneum.

The device 1 comprises a distal anchoring ring, a retractor member, aproximal ring assembly 2, a connector sleeve 3, and an instrument seal4. The distal anchoring ring and the retractor member are notillustrated in FIGS. 1 to 3. One such retractor is described in our US2005-0090717 A, the entire contents of which are incorporated herein byreference.

The distal anchoring ring is located within a wound interior, in use. Inthis case the distal anchoring ring is provided in the form of anO-ring.

The proximal ring assembly 2 is located externally of a wound opening,in use. The proximal ring assembly 2 comprises an inner ring part 5 andan outer ring part 6. In this case the inner ring part 5 is provided inthe form of an O-ring.

The retractor member may be employed to retract laterally the sides of awound opening. The retractor member extends between the distal anchoringring and the proximal ring assembly 2 in two layers. A first end of theretractor member is fixed to the inner ring part 5. The retractor memberextends distally from the inner ring part 5 to the distal anchoringring, is looped around the distal anchoring ring, extends proximallyfrom the distal anchoring ring to the proximal ring assembly 2, andextends proximally between the inner ring part 5 and the outer ring part6. The retractor member is slidably movable relative to the distalanchoring ring, and a second end of the retractor member is slidablymovable between the inner ring part 5 and the outer ring part 6.

In this case the retractor member is provided in the form of a sleeve.

The instrument seal 4 may be employed to effect a seal around aninstrument extended through the device 1. The instrument seal 4 isarranged in sealing relationship to a body of a patient, in use. Theinstrument seal 4 is spaced proximally of the proximal ring assembly 2.In this case the instrument seal 4 is of a gelatinous elastomericmaterial.

The connector sleeve 3 connects the proximal ring assembly 2 to theinstrument seal 4. The connector sleeve 3 is of a laterally flexible andlongitudinally rigid material. In this case the connector sleeve 3 is ofa rubber-like material, such as polyurethane.

FIG. 1 illustrates the offset port 1 with the rubber tube 3. FIG. 1illustrates an insufflation port 50, a gel housing 51, a gel cap 52, therubber offset tube 3, the outer proximal ring 6, and the proximal ‘O’ring 5. FIG. 2 illustrates the offset port 1 with the rubber tube 3, theinsufflation port 50, and the outer proximal ring 6. FIG. 3 illustratesthe gel 4, the gel housing 51, the proximal ‘O’ ring 5, and the rubberoffset tube 3 which is flexible enough to allow full range of motion foran instrument. The structural rigidity in the rubber offset tube wall 3allows an instrument to be passed through the valve 1 without supportfrom the surgeon's other hand.

In use, a wound opening is created in a tissue wall, and the distalanchoring ring is inserted through the wound opening into the woundinterior. The proximal ring assembly 2 is located externally of thewound opening, with the retractor member extending proximally from thedistal anchoring member through the wound opening. The second end of theretractor member is pulled proximally relative to the proximal ringassembly 2 to retract laterally the sides of the wound opening. Aninstrument may then be inserted through the instrument seal 4, extendedthrough the connector sleeve 3, extended through the retracted woundopening and into the wound interior.

In FIGS. 4 and 5 there is illustrated another instrument access device10 according to the invention, which is similar to the instrument accessdevice 1 of FIGS. 1 to 3, and similar elements in FIGS. 4 and 5 areassigned the same reference numerals.

In this case the device 10 comprises a first instrument seal 14, asecond instrument seal 24, a first connector sleeve 13 and a secondconnector sleeve 23.

The first instrument seal 14 may be employed to effect a seal around afirst instrument extended through the device 10. Similarly the secondinstrument seal 24 may be employed to effect a seal around a secondinstrument extended through the device 10. The first instrument seal 14is formed separately from the second instrument seal 24, and is spacedapart from the second instrument seal 24. The first instrument seal 14has a larger diameter than the second instrument seal 24.

The first connector sleeve 13 connects the proximal ring assembly 2 tothe first instrument seal 14. Similarly the second connector sleeve 23connects the proximal ring assembly 2 to the second instrument sleeve24.

FIG. 4 illustrates the double offset port 10. The ports 14, 24 may befor 5 mm or 10 mm or other sized instruments. FIG. 4 illustrates the gel24, e.g. 5 mm port, the gel 14, e.g. 10 mm port, the outer proximal ring6, and the rubber offset components 13, 23, which are flexible to allowfull range of instrument motion. The structural rigidity of the rubberoffset component legs 13, 23 allow the surgeon to pass instrumentsthrough the ports 14, 24 without needing to support it with his otherhand.

FIG. 5 illustrates the double offset port 10, the gel caps 52, the gels14, 24, the gel housings 51, the rubber offset components 13, 23, theproximal ‘O’ ring 5, and the outer proximal ring 6.

Referring to FIGS. 6 to 10 there is illustrated another instrumentaccess device 70 according to the invention, which is similar to theinstrument access device 10 of FIGS. 4 and 5, and similar elements inFIGS. 6 to 10 are assigned the same reference numerals. In this case aretractor 400 is illustrated and comprises a distal anchoring ring inthe form of an O-ring 401. A retractor member comprises a sleeve 402which in this case extends in two layers between the distal anchoringring 401 and the proximal ring assembly 2.

In this case the device 70 comprises a first instrument seal 71, asecond instrument seal 72, a third instrument seal 73, a first connectorsleeve 74, a second connector sleeve 75, and a third connector sleeve76.

Each instrument seal 71, 72, 73 may be employed to effect a seal arounda separate instrument extended through the device 70. Each instrumentseal 71, 72, 73 is formed separately from the other instrument seals 71,72, 73, and is spaced apart from the other instrument seals 71, 72, 73.The first instrument seal 71 has a diameter equal to the diameter of thesecond instrument seal 72. The third instrument seal 73 has a largerdiameter than the second instrument seal 72.

Each connector sleeve 74, 75, 76 connects the proximal ring assembly 2to one of the instrument seals 71, 72, 73.

Each instrument seal 71, 72, 73 comprises a sealing part 77 of agelatinous elastomeric material, and a mounting part 78 of a rigidmaterial. The sealing part 77 effects a seal around an instrumentextended through the device 70. The mounting part 78 facilitatesreleasable mounting of the instrument seal 71, 72, 73 to the connectorsleeve 74, 75, 76 in a gas-tight manner. The mounting part 78 comprisesan outwardly protruding barb 79 for an interference fit between themounting part 78 and the connector sleeve 74, 75, 76. The sealing part77 is overmoulded over part of the mounting part 78 to connect thesealing part 77 to the mounting part 78.

The device 70 comprises a connector base 80 to releasably mount theconnector sleeves 74, 75, 76 to the inner ring part 5 in a gas-tightmanner. The base 80 comprises outwardly protruding ridges 81 for aninterference fit between the base 80 and the inner ring part 5.

A rigid reinforcement ring 82 is embedded within the base 80 toreinforce the base 80.

Each connector sleeve 74, 75, 76 is inclined relative to the proximalring assembly 2 (FIG. 7).

FIG. 6 illustrates an insufflation line 83, a luer connection 84, the 5mm gel port 72, the 12 mm gel port 73, a removal ring 85, a removalribbon 86, the 5 mm gel port 71, the outer proximal ring 6, aninsufflation cup 87, the 5 mm rubber leg 74, and the 12 mm rubber leg76.

FIG. 7 illustrates the luer connector 84, the insufflation line 83, the5 mm leg 75, the insufflation cup 87, the gas seal 81, the outerproximal ring 6, the overmould support ring 82 for the triport boot 80,the 5 mm overmoulded gel 72, the 5 mm overmould tube 75, the 12 mmovermould gel 73, the 12 mm overmould tube 78, the interference fitbetween the barb 79 on the overmould tube 78 and the rubber 12 mm leg76, the triport boot 80, the inner proximal ring 5.

FIG. 8 illustrates the 5 mm gel 77 overmoulded onto the 5 mm overmouldtube 78, with the barb section 79.

FIG. 9 illustrates the 5 mm gel 77 overmoulded onto the 5 mm overmouldtube 78.

FIG. 10 illustrates the 5 mm gel overmould tube 78 with the barb 79 forthe interference fit on the 5 mm rubber leg 74.

In FIGS. 11 and 12 there is illustrated another instrument access device90 according to the invention, which is similar to the instrument accessdevice 70 of FIGS. 6 to 10, and similar elements in FIGS. 11 and 12 areassigned the same reference numerals.

In this case the connector base 80 comprises three resilient fingerprotrusions 91 which are engagable with the inner ring part 5 for asnap-fit mounting of the connector base 80 to the inner ring part 5.

FIG. 12 illustrates that a surgeon may reach under the outer proximalring 6 and press on the clip 91 using an arrow A with a finger torelease the connector base 80.

Referring to FIGS. 13 and 14 there is illustrated another instrumentaccess device 300 according to the invention, which is similar to theinstrument access device 90 of FIGS. 11 and 12, and similar elements inFIGS. 13 and 14 are assigned the same reference numerals.

In this case the connector base 80 of the device comprises an extendedskirt attachment means provided by a ring 301 having a circumferentiallyextending protrusion 302 which is engagable with the inner ring part 5for monitoring of the connector base 80 to the inner ring part 5. Thering 301 is of a shape that engages with an undercut surface 305 of theproximal ring. The advantages of this arrangement include ease ofmanufacture as the ring 301 is integral with the base 80. The engagementof the protrusion 302 with the undercut surface 305 provides aparticularly secure attachment that allows instruments to be manipulatedwithin the device. Because the protrusion 302 extends circumferentiallyfully around the ring, a surgeon can readily engage the ring 301 andpush it out of engagement with the inner ring part 5. In this way thebase 80 may be disengaged and removed if, for example, the surgeonwishes to remove a large piece of tissue, organ or body part.

Referring to FIGS. 15 and 16 there is illustrated another instrumentaccess device 100 according to the invention, which is similar to theinstrument access device 70 of FIGS. 6 to 10, and similar elements inFIGS. 15 and 16 are assigned the same reference numerals.

In this case the device 100 comprises two clamp parts 101, 102. Theclamp parts 101, 102 may be secured together around the connector base80 and the proximal ring assembly 2 to clamp the connector base 80 tothe proximal ring assembly 2.

FIGS. 17 and 18 illustrate a further instrument access device 20according to the invention, which is similar to the instrument accessdevice 10 of FIGS. 4 and 5, and similar elements in FIGS. 17 and 18 areassigned the same reference numerals.

In this case the device 20 comprises a first instrument seal 25, asecond instrument seal 26, a third instrument seal 27, a fourthinstrument seal 28, a first connector sleeve 21, a second connectorsleeve 22, a third connector sleeve 123, and a fourth connector sleeve124.

Each instrument seal 25, 26, 27, 28 may be employed to effect a sealaround a separate instrument extended through the device 20. Eachinstrument seal 25, 26, 27, 28 is formed separately from the otherinstrument seals 25, 26, 27, 28, and is spaced apart from the otherinstrument seals 25, 26, 27, 28. The first instrument seal 25 has asmaller diameter than the second instrument seal 26. The secondinstrument seal 26 has a diameter equal to the diameter of the thirdinstrument seal 27. The fourth instrument seal 28 has a larger diameterthan the third instrument seal 27.

Each connector sleeve 21, 22, 123, 124 connects the proximal ringassembly 2 to one of the instrument seals 25, 26, 27, 28.

FIG. 17 illustrates the rubber multiport cap 20 with for example 5 mmport 25, 10 mm port 26, 10 mm port 27, 12 mm port 28, and integrallymoulded sealing flanges 53. Various combinations of ports are possible.FIG. 17 also illustrates the proximal ‘O’ ring 5, the outer proximalring 6, and a docking ring 54 for the rubber multiport cap. The device20 is suitable for large incisions, for example 2-4 cm.

FIG. 18 illustrates the gel 25, for example 5 mm instrument port, thegel 26, for example 10 mm instrument port, the gel 28, for example 12 mminstrument port, the gel caps 52, the gel housings 55, the docking ring54 for the rubber port cap, the gas seal engagement point 55, theproximal ‘O’ ring 5, and the outer proximal ring 6.

FIGS. 17 and 18 illustrate the series of valves 25, 26, 27, 28 mountedon the rubber offset tubes 21, 22, 123, 124. The offset sleeves 21, 22,123, 124 are of rubber, which has enough lateral flexibility for fullinstrument range of motion, but the longitudinal structural rigidity ofthe rubber tubes 21, 22, 123, 124 means the surgeon can introduce aninstrument as a single-handed procedure.

Referring to FIGS. 19 to 21 there is illustrated another instrumentaccess device 30 according to the invention, which is similar to theinstrument access device 10 of FIGS. 4 and 5, and similar elements inFIGS. 19 to 21 are assigned the same reference numerals.

In this case both the first connector sleeve 13 and the second connectorsleeve 23 are of a longitudinally flexible material.

The first instrument seal 14 has a diameter equal to the secondinstrument seal 24.

The distal anchoring ring 31, the retractor member 32, the wound opening33, the first instrument 34 extended through the device 30, and thesecond instrument 35 extended through the device 30 are illustrated inFIGS. 19 to 21.

FIGS. 19 to 21 illustrate the twin valve sleeves 13, 23. FIG. 19illustrates the gel valve 24, the gel valve 14, and the “trousers”double sleeve 13, 23. FIG. 20 illustrates the instrument 34 inserted inthe valve 14. FIG. 21 illustrates the instruments 34, 35 in both the gelvalves 14, 24. Each can be manipulated easily without causing leakage inthe other.

The port 30 has at least two separate valves 14, 24 for individualinstruments 34, 35. Each valve 14, 24 have its own sleeve portion 13,23. Consequently, movement of any instrument 34, 35 should not affectthe seal around any other instrument 34, 35.

In FIGS. 22 to 25 there is illustrated another instrument access device40 according to the invention, which is similar to the instrument accessdevice 30 of FIGS. 19 to 21, and similar elements in FIGS. 22 to 25 areassigned the same reference numerals.

In this case the instrument seals 14, 24 are located at the proximalring assembly 2. No connector sleeves are provided.

FIG. 22 illustrates the first gel 14, a dividing wall 56, and the secondgel 24. FIG. 23 is a plan view of the device 40. FIG. 24 illustrates thefirst gel semicircle 14, the second gel semicircle 24, and holes 57 forlocating pins. The gels 14, 24 are split in two. Two instruments 34, 35can be used. Because they are in independent gels 14, 24 neither causesleaks in the other.

Referring to FIGS. 26 to 48 there is illustrated a method of performinga surgical procedure according to the invention. In this case thesurgical procedure performed is a laparoscopic cholecystectomyprocedure.

A number of medical devices may be employed to perform the procedure forexample a scalpel 201, an introducer device 202, an instrument accessdevice 203, an insufflator 204, a camera device 205, and varioussurgical instruments 206.

In use, the introducer device 202 and the instrument access device 203are supplied in a pack 207. The pack 207 is opened (FIG. 26), and theintroducer device 202 and the instrument access device 203 are removedfrom the pack 207 (FIG. 27).

FIG. 26 illustrates the peel off lid 208, the triport device 203, theinjector introducer 202, and the plastic blister pack tray 207 which isa sterile pack. In FIG. 26 the user peels open the tray lid 208. FIG. 27illustrates the injector introducer 202, the thumbswitch 209, the bluntdissecting tip 210, the distal ring 211, the sleeve 212, the removalribbon 213, the removal ring 214, the insufflation line 215, the 5 mmports 216, the 12 mm port 217, and the outer proximal ring 218. In FIG.27 the user removes the introducer 202, and the triport 203.

The distal ring 211 of the instrument access device 203 is inserted intothe introducer device 202 (FIG. 28), and the scalpel 201 is used tocreate a wound opening 219 (FIG. 29).

In FIG. 28 the user inserts the distal ring 211 into the end of theinjector introducer 202. FIG. 29 illustrates the scalpel 201, the blade220, and the abdominal wall 221. In FIG. 29 the surgeon creates either a15-20 mm skin incision 219 through the skin and the fascia layers butnot through the peritoneum, or cuts all the way through to the abdominalcavity with a Hasson cut-down incision 219.

The introducer device 202 is inserted through the wound opening 219until the distal ring 211 of the instrument access device 203 is withinthe wound interior (FIGS. 30 and 31).

In FIG. 30 the tip of the injector introducer 202 is placed in the skinincision 219 or the Hasson cut-down incision 219. In the case of theskin incision, downward pressure and axial rotation of the injectorintroducer 202 cause the blunt dissecting tip 210 to burrow through theperitoneum to the abdomen (FIG. 31). This may take place while theabdomen is insufflated. In the case of the Hasson cut-down incision, theinjector 202 is easily passed through the pre-made incision (FIG. 31).

The thumbstitch 209 of the introducer device 202 is depressed to ejectthe distal ring 211 of the instrument access device 203 into the woundinterior (FIG. 32), and the introducer device 202 is removed from thewound opening 219 (FIG. 33).

In FIG. 32 the thumbswitch 209 is pressed downwards to eject the distalring 211.

In FIG. 33 the injector introducer 202 is removed from the incision 219leaving the distal ring 211 in the abdomen. The sleeve 212 is pulledupwards to engage the distal ring 211 with the underside of theabdominal wall.

The sleeve 212 of the instrument access device 203 is pulled proximallyand the outer proximal ring 218 is pushed distally to retract laterallythe sides of the wound opening 219 (FIG. 34). The excess sleeve materialis cut-away, and the removal ribbon 213 is pulled proximally to removeany excess ribbon from the wound interior (FIG. 35).

In FIG. 34, the user keeps upward tension on the sleeve 212, and theouter proximal ring 218 is pushed down until sufficient retraction isachieved. In FIG. 35 the removal ribbon 213 is gently pulled to removeslackness from inside the abdomen. The excess sleeve 212 is cut andremoved.

The insufflator 204 is connected to the insufflation line 215 toinsufflate the abdomen (FIG. 36), and one or more instruments 206 may beinserted through the ports 216, 217 (FIG. 37).

FIG. 36 illustrates the insufflation supply 204, the insufflation line215, the gel ports 216, 217. In FIG. 36 the insufflation line 215 isattached to the insufflation supply 204. In FIG. 37 up to threeinstruments 206 may be used simultaneously through the triport 203. Eachleg 216, 217 have an individual gel valve on top. The legs 216, 217 arerubbery and so can accommodate the instruments 206 moving off axis.Moving one instrument 206 does not cause leaks in either of the othertwo instruments 206.

Instruments 206 may be inserted through the ports 216, 217 of theinstrument access device 203 to access the wound interior, and/or thecamera 205 may be inserted through one of the ports 216, 217 to accessthe wound interior (FIG. 38). In this case the camera 205 has a lightsource 222 inclined at an angle to the longitudinal axis of the camera205, and the instruments 206 are straight.

In FIG. 38 there are two 5 mm ports 216 and one 12 mm port 217. FIG. 38illustrates the 5 mm camera 205, the 5 mm instruments 206, theinsufflation supply 204, the abdominal wall 221, and the 12 mm port 217.

One of the instruments 206 may be used to pivot the gall bladder 223upwards and also pivot the liver 224 upwards (FIG. 39). The otherinstrument 206 may then be issued to clamp the cystic bile duct and tosever the gall bladder 223 for removal.

FIG. 39 illustrates the straight retracting instrument 206, the gallbladder 223, the liver 224, and the dissecting instrument 206. In FIG.39 the straight retracting instrument 206 grasps the gall bladder 223and lifts it up. This also retracts the liver 224 out of the way. Thedissecting instrument 206 can then isolate the gall bladder 223. Visionis provided by the 5 mm scope 205.

One of the instruments 206 may have a bend or curved section 225 closeto the instrument distal end (FIGS. 40 and 41). The bend section 225 maybe a fixed bend.

FIG. 40 illustrates the 5 mm shaft 206, the bent/bendable instrument 206with the end effector 226 which may rotate, the 12 mm end effector 227,and the rotating thumbwheel 228 which may rotate the end effector 226.

FIG. 41 illustrates the bent instrument 206 retracting the gall bladder223, the liver 224, and the increased distance between the instrumenthandle 229 and the laparoscope 205. Using the retracting instrument 206with the bend 225 near the end effector 226 or near the handle 229 orboth, enables the handle 229 to rest further away from the laparoscope205 and other instrument handles, thereby reducing clutter/interference.

One or more of the instruments 206 may have a bend or curved section 230close to the instrument proximal end (FIG. 42).

In FIG. 42 the bendable or bent shafts 206 near the handle 229 and/orthe end effector 226 may increase the space available for the surgeon'shands.

The radius of curvature of the bend or curved section 225 of theinstrument 206 and the length of the end effector 226 may be varied tosuit requirements. For example, in FIGS. 43 and 44, the instrument 206has a larger radius of curvature bent/curved section 225, and a largerend effector 226. The light source 222 may be provided parallel to andin-line with the longitudinal axis of the camera 205 (FIGS. 43 and 44).

FIG. 43 illustrates the in-line light source 222 on the laparosope 205,the curved shaft 206, and the large head grasper 226, e.g. up to 4 cm.

FIG. 44 illustrates the grasping instrument 206 in the non-dominanthand, the dissecting instrument 206 in the dominant hand, the in-linelight source 222, the gall bladder 223, and the liver 224.

One or more body parts, for example the severed gall bladder 223 may beremoved from the wound interior. The body part may be removed throughthe ports 216, 217 of the instrument access device 203 (FIGS. 45 and46).

Alternatively the valve ports 216, 217 may be detached from a retractorbase 231 of the instrument access device 203 (FIG. 47), and the bodypart may be removed through the retractor base 231 (FIG. 48).

FIG. 45 illustrates the 12 mm valve 217, and the resected gall bladder223. Due to the highly elastic nature of the gel material, specimenssuch as the gall bladder 223 may be extracted through the large 12 mmleg 217 of the triport 203 (FIG. 46).

FIG. 47 illustrates the triport valves 216, 217 removed from theretractor base 231, the retracted and protected incision 219, and theresected gall bladder 223. The gall bladder 223 is easily removedthrough the retracted/protected incision 219 (FIG. 48). The triportvalves 216, 217 may be re-attached for final laparoscopic examinationprior to removing the device 203 at the end of the procedure.

Referring to FIG. 49 there is illustrated an instrument access device ofthe invention which has some parts similar to those described above.

The device comprises first, second and third instrument seals 500, 501,502 respectively for sealing around instruments extended through thedevice. The seals 500, 501, 502 have respective connector sleeves 503,504, 505. Each sleeve 503, 504, 505 connects a base 510 to one of theinstrument seals 500, 501, 502. The device also comprises twoinsufflation/desufflation ports 515, 516. Each of the ports 515, 516comprises a connector 517 extending from the base 510, a tube 518extending from the connector 517, a luer connector 519 and a removablecap 520. The luer connector 519 is used for connection to any suitablesupply line for insufflation gas or for discharge if insufflation gas.In use, the insufflation/desufflation ports 515, 516 facilitateindependent control of insufflation and desufflation as may be requiredduring a surgical procedure. In this way the operating conditions may beoptimised.

Details of the retractor and proximal ring arrangement are similar tothose described above and like parts are assigned the same referencenumerals.

Referring to FIG. 50 there is illustrated another instrument accessdevice which is similar to that described above with reference to FIGS.15 and 16 and like parts are assigned the same reference numerals. Inthis case the two clamp parts 101, 102 are fastened together and retainthe proximal end of the sleeve 402.

Referring to FIG. 51 there is illustrated another instrument accessdevice of the invention. In this case a collar 600 is fitted over theouter proximal ring of the device, trapping excess sleeve 402 at theproximal end and thereby removes it from the field of use.

Referring now to FIG. 52 there is illustrated a further instrumentaccess device of the invention. In this case access sleeve 402 at theproximal end is cut-off, folded over the inner proximal ring 5 and isheld in place between the base 510 and the inner proximal ring 5 whenthe base 510 is fitted.

The devices of FIGS. 51 and 52 are particularly advantageous as theproximal end of the sleeve 402 that is generated when the sleeve 402 ispulled upwardly to retract an incision is removed from the field of use.

Referring to FIG. 53 there is illustrated an instrument access device701 according to the invention which in this case comprises threeinstrument insertion sealing devices according to the invention. Theaccess device 701 comprises a first instrument insertion device 702, asecond instrument insertion device 703, and a third instrument insertiondevice 704. The access device also has two insufflation/desufflationports 706, 707.

The first instrument insertion device is illustrated particularly inFIGS. 54 to 59 and is shown, in use, in FIGS. 63( a) to 63(c). Theinsertion device 702 comprises a lipseal 710 through which an instrument711 is insertable and a second seal member 712 having a passageway 713extending therethrough, through which the instrument 711 is insertable.The first insertion device also has a reducer cap 715 which has afurther lipseal 716 which is smaller than the lipseal 710. To insertlarge diameter instruments, the cap 715 is removed (FIGS. 54, 56). Toinsert smaller diameter instruments the cap 715 is in place (FIG. 55).

The second seal member 712 in this case comprises a duckbill valvethrough which the instrument 711 passes. The duckbill valve 712 providessealing engagement with the instrument shaft whilst accommodatinglateral movement of the instrument as illustrated in FIGS. 63( a) to63(c).

The lipseal valve 710 is located proximally of the duckbill valve 712 sothat a double seal is provided to substantially prevent leakage ofinsufflation gas.

The second and third instrument insertion devices 703, 704 may be of thesame construction as that of the first instrument insertion device 702.

The instrument access device of the invention is suitable for use duringlaparoscopic surgery to facilitate instrument access to an insufflatedabdominal cavity while maintaining pneumoperitoneum.

The instrument access device of the invention comprises a firstconnector sleeve 720 for connecting the first seal assembly 702 to aconnector base 725, a second connector sleeve 721 for connecting thesecond seal assembly 703 to the base 725, and a third connector sleeve722 for connecting the third seal assembly 704 to the base 725.

The base 725 is mounted to a proximal ring assembly 726 of a retractorwhich includes a sleeve 727 which in this case extends in two layersbetween a distal anchoring ring (not shown) and the proximal ringassembly 726. One such retractor is described in our US 2005-0090717A,the entire contents of which are incorporated herein by reference.

The instrument seals 702, 703, 704 are arranged in sealing relationshipto a body of a patient, in use. The instrument seals 702, 703, 704 arespaced proximally of the proximal ring assembly 726.

The connector sleeves 720, 721, 722 connect the proximal ring assembly726 to the instrument seals 702, 703, 704. The connector sleeves 720,721, 722 are of a laterally flexible and longitudinally rigid material.In one case the connector sleeves 720, 721, 722 are of a rubber-likematerial, such as polyurethane.

In use, a wound opening is created in a tissue wall, and the distalanchoring ring is inserted through the wound opening into the woundinterior. The proximal ring assembly 726 is located externally of thewound opening, with the retractor member extending proximally from thedistal anchoring member through the wound opening. The second end of theretractor member is pulled proximally relative to the proximal ringassembly 726 to retract laterally the sides of the wound opening.Instruments may then be inserted through the instrument seals 702, 703,704, extended through the connector sleeves 720, 721, 722, and extendedthrough the retracted wound opening and into the wound interior.

The lipseal 710 may be of any suitable material. For example, it may beof an elastomeric material, a foam—type material or a gelatinousmaterial. The duckbill valve 712 may be of any suitable material. Forexample, it may be of a flexible polymeric material.

A lipseal valve 10 may also be used in combination with a block 740 of agelatinous material to provide a second seal (FIG. 58).

Referring to FIGS. 59 to 62, for improved gas tightness the lipsealvalve 710 may additionally be provided with a distal sealing flap. Inone case (FIG. 60) a sealing flap 741 is integral with the valve 710. Inanother case (FIG. 61) a sealing flap 742 is mounted to the distal endof the valve 710 using any suitable mounting such as adhesive and/ormechanical fixing. In a further case (FIG. 62) a sealing flap 743 isfixed to a valve housing 744 using any suitable fixing. The use of suchflaps may enhance the sealing of the valve assembly to an instrumentpassing therethrough.

Various features of the invention are described and illustrated. It willbe appreciated that at least some of the features described in relationto one embodiment may be used not only in the embodiment specificallydescribed but also in other appropriate embodiments.

The invention is not limited to the embodiments hereinbefore described,with reference to the accompanying drawings, which may be varied inconstruction and detail.

1. An instrument access device comprising a first instrument seal toeffect a seal around a first instrument extended through the device, anda second instrument seal to effect a seal around a second instrumentextended through the device, the instrument seals being configured to bearranged in sealing relationship to a body of a patient; a distalanchoring member for location within a wound interior; a retractormember extending proximally from the distal anchoring member to retractlaterally the sides of a wound opening; a proximal member for locationexternally of a wound opening; and a connector member to connect theproximal member to the instrument seal, the proximal member and theconnector member being configured for retaining a proximal end of theretractor member.
 2. A device as claimed in claim 1 wherein theconnector member is engagable with the proximal member.
 3. A device asclaimed in claim 1 wherein the outer radial dimension of the connectormember is greater than that of the proximal member.
 4. A device asclaimed in claim 1 wherein the outer radial dimension of the connectormember is less than that of the proximal member.
 5. A device as claimedin claim 3 wherein the connector member comprises an inner collar forengagement with the proximal member.
 6. A device as claimed in claim 4wherein the connector member comprises an outer collar for engagementwith the proximal member.
 7. A device as claimed in claim 1 wherein theconnector member is releasably mounted to the proximal member.
 8. Adevice as claimed in claim 1 wherein the connector member is mounted tothe proximal member in an interference fit arrangement.
 9. A device asclaimed in claim 1 wherein the connector member is mounted to theproximal member in a snap-fit arrangement.
 10. A device as claimed inclaim 9 wherein the connector member comprises at least one protrusionfor engagement with the proximal member.
 11. A device as claimed inclaim 1 wherein the retractor member extends at least between the distalanchoring member and the proximal member.
 12. A device as claimed inclaim 11 wherein the retractor member extends in two layers between thedistal anchoring member and the proximal member.
 13. An instrumentaccess device comprising a first instrument seal to effect a seal arounda first instrument extended through the device, and a second instrumentseal to effect a seal around a second instrument extended through thedevice, the instrument seals being configured to be arranged in sealingrelationship to a body of a patient; the device comprising at least twoports for insufflation and/or desufflation.
 14. A device as claimed inclaim 13 wherein the device comprises an insufflation port and adesufflation port.
 15. A device as claimed in claim 13 wherein the portsare laterally spaced-apart.
 16. A device as claimed in claim 13 whereinthe port comprises a connector member.
 17. A device as claimed in claim16 wherein the connector member comprises a sleeve.
 18. A device asclaimed in claim 16 wherein the connector member is of a laterallyflexible material.
 19. A device as claimed in claim 16 wherein theconnector member is of a longitudinally rigid material.
 20. A device asclaimed in claim 16 wherein the connector member is of a rubber-likematerial.